Postgraduate Diploma in ISO 13485, QMS and Validation
Online Postgraduate Diploma of 800 h in ISO 13485, QMS and Validation. 8 modules covering ISO 13485:2016, Regulation (EU) 2017/745 and Greenlight Guru. Assigned tutor and open enrolment.
Postgraduate Diploma in ISO 13485, QMS and Validation — studying from the United States
Electronics and telecommunications are foundational to the American economy, with research and manufacturing hubs in California, Texas, Arizona, New York and Oregon. Semiconductor investments and wireless network deployment are driving demand for hardware, firmware and systems engineers. Embedded systems now appear across automotive, medical, industrial and consumer products, requiring expertise in real-time software and secure design. Regulatory compliance with federal spectrum and safety rules is a key part of professional practice.
Fees for the United States: US$2,000 (US Dollars), with instalments and employer sponsorship available.
Relevant bodies in the United States
Typical roles
Questions from the United States
Which US bodies relate to electronics, embedded systems and telecom engineering?
The IEEE is the main professional body for electronics and telecom engineers in the US, and it publishes widely used standards. The Federal Communications Commission (FCC) regulates radio and telecom equipment. Professional Engineer licensure from state boards exists but is less common in this field. SEIUM's qualifications are private and not official degrees, so recognition rests with employers or relevant bodies.
How do US electronics and telecom employers regard private online qualifications?
US semiconductor, telecom and embedded-systems employers typically look for accredited degrees, hands-on design experience and familiarity with relevant standards. A private online qualification can document focused study, but it is not a standard requirement and its value is decided by each employer. Practical design projects and certifications often carry more weight.
Can I study embedded systems from the US around a full-time role?
Yes, the programmes are online, taught in English, and do not need a student visa. The commitment is roughly 1,900 hours for a master's, 800 hours for a postgraduate diploma, or 300 hours for a specialist course. An assigned technical tutor supports your progress. Fees can be paid in instalments, and some employers fund training, so ask whether your employer offers support.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Implement a quality management system compliant with ISO 13485.
Apply design controls and traceability.
Control the production processes of medical devices.
Validate special processes using IQ, OQ and PQ protocols.
Validate the quality system software using a risk-based approach.
Manage CAPA, complaints and surveillance.
Prepare for audits by notified bodies and the FDA.
Who it's for
- Quality manager looking to specialise in ISO 13485, QMS and Validation.
- Validation engineer looking to specialise in ISO 13485, QMS and Validation.
- ISO 13485 internal auditor looking to specialise in ISO 13485, QMS and Validation.
- Regulatory affairs specialist looking to specialise in ISO 13485, QMS and Validation.
- Manufacturing process engineer looking to specialise in ISO 13485, QMS and Validation.
- CAPA technician looking to specialise in ISO 13485, QMS and Validation.
- Graduates in engineering or science seeking to enter the medical device sector.
What you'll work with
- ISO 13485:2016
- Reglamento (UE) 2017/745
- 21 CFR Part 820
- ISO 14971
- 21 CFR Part 11
- ISO/TR 80002-2
- ISO 11607-1
- ISO 14644-1
8 modules · 800 h
1.1Structure and scope of ISO 13485:20161.2Differences from ISO 90011.3Integrated regulatory requirements1.4Risk-based approach1.5Quality manual and documentation1.6Document and record control1.7Management responsibility1.8Resource management and competence1.9Infrastructure and work environment1.10Case study: process map of a manufacturer
2.1Design and development planning2.2Design inputs and outputs2.3Design reviews2.4Design verification and validation2.5Transfer to production2.6Design change control2.7Design History File (DHF)2.8Integration of usability and risk2.9FDA design control requirements2.10Workshop: design traceability matrix
3.1Production planning3.2Device Master Record (DMR) and Device History Record (DHR)3.3Cleaning and contamination control3.4Identification and traceability3.5Supplier control and purchasing3.6Measuring equipment and calibration3.7Nonconforming product3.8Sterilisation and packaging3.9ISO 14644 cleanroom requirements3.10Practice: process control plan
4.1Special processes and their validation4.2IQ, OQ and PQ protocols4.3Statistics for validation4.4Justified sample sizes4.5Validation of sterilisation processes4.6Packaging seal validation to ISO 116074.7Revalidation and change control4.8Validation documentation4.9GHTF guidance on process validation4.10Laboratory: capability analysis in Minitab
5.1Software in the quality system5.2ISO/TR 80002-2 and its approach5.3GAMP 5 risk-based approach5.4Validation of computerised systems5.521 CFR Part 11 and electronic signatures5.6Data integrity ALCOA+5.7Validation of spreadsheets5.8Software as a service and suppliers5.9Computer software assurance5.10Case study: validation of an eQMS
6.1Feedback and complaints6.2Surveillance and incident reporting6.3Internal audits6.4Corrective and preventive actions (CAPA)6.5Root cause analysis6.6Data analysis and trends6.7Management review6.8Post-market follow-up6.9Recall management6.10Practice: complete CAPA investigation
7.1Notified body audits7.2MDSAP programme7.3FDA Quality Management System Regulation (QMSR)7.4FDA inspections and Form 4837.5Unannounced audits7.6Supplier audits7.7Staff preparation for audits7.8Responding to findings7.9Maintaining certification7.10Case study: response to a major nonconformity
8.1System organisation and scope8.2Gap analysis against ISO 134858.3Documented key processes8.4Design control plan8.5Process validation protocol8.6Software validation plan8.7Audit programme8.8Certification roadmap8.9Report and presentation8.10Final review with the tutor
How you'll learn
100% online training on the SEIUM campus, with downloadable material, recorded classes and assigned technical tutor. No fixed timetable: students progress at their own pace within the enrolment period, making it possible to combine with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Greenlight Guru, MasterControl, Veeva Vault QMS, Minitab, in free, academic or evaluation versions. Tests are studied using real IQ/OQ/PQ process validation procedures, internal QMS audit and validation of a computerised system. Assessment is continuous per module plus the final integrative project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Implement a quality management system compliant with ISO 13485.
Apply design controls and traceability.
Control the production processes of medical devices.
Validate special processes using IQ, OQ and PQ protocols.
Validate the quality system software using a risk-based approach.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. No university degree is required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient Spanish to follow technical regulatory reading.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme is 800 hours in total, spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with full-time work.
Work is carried out with Greenlight Guru, MasterControl, Veeva Vault QMS, Minitab. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An SEIUM own diploma upon passing the continuous assessment and the integrative project. It is in-house training, not an official qualification from the Ministry.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised towards the advanced programme. Check the recognition policy when you enrol.
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